Regulatory Affairs Specialist
Vor 2 Tagen
Your key responsibilities will include:
* Creating, reviewing, and updating high-quality CMC documentation to obtain and maintain product approvals, ensuring compliance with global regulatory requirements
* Implementing change control processes, coordinating regulatory assessments, and maintaining CMC submission and approval status
* Handling and managing inquiries related to quality documentation from authorities, ensuring timely and accurate responses
* Overseeing regulatory CMC projects, communicating with Merz representatives and partners, and coordinating third-party services
* Developing regulatory CMC strategies and representing regulatory requirements in project teams and interdisciplinary teams
* Maintaining a detailed understanding of global and national CMC regulatory requirements and best practices
To succeed in this role, you will need:
* Completed scientific studies in Pharmacy, Biology, Chemistry, or a related field of studies, a doctorate is an advantage
* 3-5 years in regulatory affairs or in a department responsible for CMC matters, such as analytics, development, or quality control
* Strong communication skills, including profound English
* Analytical and systemic thinking
* Strong negotiation skills and teamwork
* Solution-oriented with a focus on compliance and quality
In return, you can expect:
* Individual career development in a purposeful job: you improve the quality of life of our patients
* Hybrid work model that allows a good work-life balance
* Attractive location with good transport links, modern workplaces, and a company restaurant
* Global family business with flat hierarchies and an open, respectful corporate culture
* Attractive remuneration with extensive social benefits
* Variety of employer-subsidized benefits such as WellPass, Germany ticket, Corporate Benefits, and JobBike
Join us in our mission to improve treatment outcomes for patients around the world and become part of our international and motivated Merz Therapeutics family now"}
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